West Chester, PA – Thursday, March 30th, 2023 – Acero Precision, a manufacturer of precision medical devices and analytical medical equipment, has obtained the Certificate of Good Manufacturing Practices Certification, issued by ANVISA, attesting that this organization complied with Good Manufacturing Practices (GMP) during the most recent audit.
The National Health Surveillance Agency or ANVISA (Agência Nacional de Vigilância Sanitária) is the Brazilian regulatory agency that is responsible for the approval and supervision of food, cosmetics, tobacco, pharmaceuticals, health services, and medical devices, among others.
Anvisa GMP certification is an assessment performed by ANVISA inspectors to ensure that a factory, anywhere in the world, complies with the requirements determined by Brazilian legislation based upon audit sampling criteria. Complying with the GMP, Acero Precision has been inspected and evaluated in the physical production and manufacturing areas, storage and Quality Control, as well as the Quality Assurance System.
“Widely recognized as one the most difficult certifications to obtain, this ANVISA GMP Certification is a huge accomplishment and milestone for our team,” said President and CEO Michael Fitzgerald, “This certification further validates and strengthens our top tier processes and practices, and will ease the path to producing new components for industries and new markets around the world.”
With ANVISA awarding Acero Precision with GMP certification, they are now qualified to manufacture medical OEM products for the Brazilian market for all OEMs.
As a leading OEM (Original Equipment Manufacturer), Acero Precision is also compliant with FDA registrations and actively holds both ISO 13485:2016 and ISO 9001: 2015 certificates. With these ISO certifications, paired with the ANVISA GMP Certification, Acero continues to demonstrate and strengthen its commitment to providing safe and effective medical devices and components in the market.
About Acero Precision:
Acero Precision manufactures precision products in the medical, aerospace, industrial, motorsports, and musical industries. With a state-of-the-art facility expanding over 65,000 square feet of manufacturing space, Acero Precision is continually investing in the machining, finishing, resources, and team members that make innovation possible. Our current team of over 110 employees is fully committed to producing world class products and components from conception to full production and packaging. Acero Precision’s facility houses many high performance Star, LNS, and Mazak CNC machines while offering a full spectrum of on-site capabilities, including: end-to-end precision manufacturing, passivation, finishing and cleaning, and micro surface blasting technologies.
Interested in working at Acero Precision?
Acero Precision is inviting everyone interested in a position or with questions to reach out to firstname.lastname@example.org or 484-653-0259. You can also head to aceroprecision.com under the ‘careers’ tab to apply to current open positions.